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510(k) K231728

BiWaze Clear System by Abmrc, LLC — Product Code NHJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 2024
Date Received
June 13, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Positive Pressure Breathing, Intermittent
Device Class
Class II
Regulation Number
868.5905
Review Panel
AN
Submission Type

Other clearances by Abmrc, LLC

  • K213564 — BiWaze Clear System (December 21, 2022)
  • K191912 — BiWaze Cough (March 27, 2020)

Other clearances for product code NHJ

  • K242438 — Clearo (May 16, 2025)
  • K213564 — BiWaze Clear System (December 21, 2022)
  • K200988 — Maximus System (May 26, 2020)
  • K191912 — BiWaze Cough (March 27, 2020)
  • K192143 — Maximus System (February 14, 2020)
  • K151689 — MetaNeb 4 System (March 17, 2016)
  • K140598 — PEGASO COUGH, PEGASO A-COUGH, PEGASO A-COUGH PERC (October 16, 2014)
  • K140605 — MINIPEGASO COUGH, MINIPEGASO A-COUGH, MINIPEGASO A-COUG PERC (October 3, 2014)
  • K132988 — VITAL COUGH (March 28, 2014)
  • K124032 — METANEB (April 25, 2013)